Data from the 4 studies, referred to as ZOOS I-IV, respectively, reaffirm that Zensana(TM) 8 mg dose is statistically bioequivalent
to the current commercially available 8 mg ondansetron (Zofran(R)) tablet, and can be conveniently administered in multiple doses.
Hana Biosciences (AMEX:HBX), a biopharmaceutical company focused on advancing cancer care, announced the positive results of pivotal clinical trial ZOOS 1 (Zensana(TM) Ondansetron Oral Spray), a study which definitively demonstrated Zensana(TM) (ondansetron oral spray) 8 mg dose is bioequivalent
to the current commercially available 8 mg tablet (Zofran(R); GlaxoSmithKline).
Results demonstrated the tacrolimus and Prograf capsules are bioequivalent
under fed and fasting conditions.
Under data exclusivity, a controversial rule first imposed in 1987, for a period of about eight years after approval of a new drug, a country cannot accept an application for a generic bioequivalent
to a brand-name drug even if the patent is expired or is otherwise not a problem, because that is called "unfair" use of the knowledge that the brand-name drug worked in the first place.
over PR Newswire, we are advised by a representative of the company that the first paragraph, second sentence should read "Endo's oxycodone extended-release tablets are AB-rated bioequivalent
versions of the 10mg, 20mg and 40mg strengths of OxyContin(R), a product of The Purdue Frederick Company that is indicated for the management of moderate-to-severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time" rather than ".
812) would let the Food and Drug Administration approve generic drugs that are not bioequivalent
to their brand-named counterparts.
Fluocinonide E Cream is bioequivalent
to Medicis' Lidex(R), and the market for this product is estimated by industry sources to be approximately $5,000,000.
has announced that the United States Food and Drug Administration has accepted its Abbreviated New Drug Application (ANDA) submission for a bioequivalent
version of Depakote(R).
The FDA has determined that these formulations, which will be manufactured at Bentley's facilities in Spain, are bioequivalent
and have the same therapeutic effect as that of the reference drug, Zocor([R]) (Merck & Co.
It is a bioequivalent
of Roche's Klonopin, with an estimated total US drug market of $140 million.
Diflorasone Diacetate Cream is bioequivalent
to Dermik Laboratories' Psorcon(R) Cream.
The breadth of his business experience will allow him to make a major contribution to the development and marketing of bioequivalent
products utilizing the ACCU-BREAK[TM] technologies, as well as allowing him to play an important role in our technology out-licensing efforts.